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Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00316615
First received: April 19, 2006
Last updated: September 13, 2006
Last verified: September 2006
History of Changes
  Purpose

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administered to Non-Elderly Adults and Elderly Subjects


Condition Intervention Phase
Influenza Disease
 Biological: influenza vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, When Administered to Non-Elderly Adult and Elderly Subjects

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination

Secondary Outcome Measures:
  • Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Estimated Enrollment: 100
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • subjects 18 years of age or older

Exclusion Criteria:

  • Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure
  • hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • known or suspected (or high risk of developing) impairment/alteration of immune function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316615

Locations
Italy
G. D'Annunzio University
Chieti, Italy, 66100
Office of Hygiene and Public Health, ASL Lanciano
Lanciano, Italy
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316615     History of Changes
Other Study ID Numbers: V71P3S, Eudract number: 2005-000622-23
Study First Received: April 19, 2006
Last Updated: September 13, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by Novartis:
influenza
non elderly adult and elderly
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013